Device and method for treatment of sinusitis

ABSTRACT

A method of treating a constricted sinus passageway in a frontal sinus of a patient includes forming an artificial passageway into the frontal sinus of the patient with a tool. An elongate member having an inflation member thereon is inserted through the passageway. The inflation member is positioned with the constricted sinus passageway and the inflation member is expanded so as to expand at least a portion of the constricted sinus passageway.

RELATED APPLICATIONS

This Application is a continuation of U.S. application Ser. No.11/379,691 filed on Apr. 21, 2006, now issued as U.S. Pat. No.7,520,876. Priority is claimed pursuant to 35 U.S.C. §120 and all otherapplicable statutes. The '691 application is incorporated by referenceas if set forth fully herein.

FIELD OF THE INVENTION

The field of the invention generally relates to devices and methods forthe treatment or amelioration of sinusitis.

BACKGROUND OF THE INVENTION

Sinusitis is a condition affecting over 35 million Americans, andsimilarly large populations in the rest of the developed world.Sinusitis occurs when one or more of the four paired sinus cavities(i.e., maxillary, ethmoid, frontal, sphenoid) becomes obstructed. Thesepaired cavities are located in the skull behind the face, as is depictedin FIGS. 1, 2, and 3A. Normally the sinus cavities, each of which arelined by mucosa, produce mucous which is then moved by beating ciliafrom the sinus cavity out to the nasal cavity and down the throat. Thecombined sinuses produce approximately one liter of mucous daily, so theeffective transport of this mucous is important to sinus health.

Each sinus cavity has an opening into the nasal passage called anostium. When the mucosa of one or more of the ostia or regions near theostia become inflamed, the egress of mucous is interrupted, setting thestage for an infection of the sinus cavity, i.e., sinusitis. Infectionsof the maxillary and/or ethmoid sinuses make up the vast majority ofcases of sinusitis, with far fewer cases involving the sphenoids andfrontals.

Though many instances of sinusitis may be treatable with antibiotics, insome cases sinusitis persists for months, a condition called chronicsinusitis. Some patients are also prone to multiple episodes ofsinusitis in a given period of time, a condition called recurrentsinusitis.

Currently, patients experiencing chronic sinusitis are eligible to havea surgical procedure called functional endoscopic sinus surgery (FESS).In this procedure, which almost always done in an operating room settingwith the patient under general anesthesia, surgical cutting instrumentsare guided with an endoscopic visualization tool to the various sinusostia and adjacent regions. Inflamed mucosa and underlying bony tissueare cut away in an effort to widen the outlet of the sinuses ofinterest. Once opened, the infected sinuses are able to drain and returnto a relatively normal state.

While this procedure is generally effective, it is a relatively invasiveprocedure to the nasal cavity and sinuses. There can be significantpost-operative pain for the patient, and sometimes there are bleedingcomplications that require packing to be placed in the nasal cavity.Subsequent removal of this packing can be quite painful. Also, since thenasal and sinus tissue are significantly traumatized, it may takeseveral days to weeks to know whether the surgery was successful. Thisis especially true if various healing agents such as MeroGel®(Medtronic/Xomed) were placed at the surgical site, as these often blockthe sinus drainage until they are flushed away or degrade away afterseveral days.

Additionally, in certain patients, the ostial regions of thesurgically-treated sinuses can become re-obstructed with excess growthof scar tissue as a result of the tissue trauma. When the advantages anddisadvantages of the surgery are considered for a patient withsinusitis, there are many patients in whom the surgery may not beappropriate. For example, their condition may not be considered “chronicenough” or extensive enough to warrant FESS surgery. In othersituations, the patient may be fearful of the pain or other aspects ofhaving FESS performed. Alternatively, the FESS procedure may be toocostly for a particular patient.

For these and other reasons, there is a clear need for better methodsand devices for the treatment of sinusitis.

SUMMARY OF THE INVENTION

In a first aspect of the invention, a method of treating a constrictedsinus passageway of a patient includes traversing the canine fossaregion of the patient so as to form a passageway to a sinus cavity. Anelongate member having an inflation member thereon (e.g., a balloon) isinserted through the passageway. The inflation member is positionedwithin the constricted sinus passageway. The inflation member is thenexpanded so as to expand at least a portion of the constricted sinuspassageway.

In a second aspect of the invention, a method of accessing a constrictedsinus passageway of a patient includes traversing the canine fossaregion of the patient to as to form a passageway to a sinus cavity. Avisualization tool is inserted through the passageway. A wire guide isalso inserted through the passageway. The constricted sinus passagewayis viewed with the visualization tool. The wire guide is positionedadjacent to or within the constricted sinus passageway.

In another aspect of the invention, a method of accessing a constrictedsinus passageway of a patient includes traversing the canine fossaregion of the patient so as to form a first passageway to a sinuscavity. A visualization tool is inserted through the first passageway.The canine fossa region is traversed again to form a second passageway.This traversal may be performed at the same time that the firstpassageway is formed. A wire guide is then inserted through the secondpassageway. The constricted sinus passageway is then viewed with avisualization tool. The wire guide is then placed adjacent to or withinthe constricted sinus passageway. A balloon catheter may be advancedover the wire guide to expand or open the constricted sinus passageway.

In yet another embodiment, a method of accessing a constricted sinuspassageway of a patient includes traversing the canine fossa region ofthe patient so as to form a passageway to a sinus cavity. Anillumination member is inserted into the sinus cavity. The sinus cavityis illuminated via the illumination member. A guide catheter is insertedthrough the nasal passageway, the guide catheter including a wire guideslidably disposed within a lumen contained therein. A visualization toolis inserted through the nasal passageway. A distal tip of the wire guideis placed across or adjacent to the constricted sinus passageway.

In still another aspect of the invention, a method of confirming thelocation of a wire guide intended to be positioned within a patient'ssinus cavity includes introducing a wire-guide through a nasalpassageway to place a distal tip of the wire guide in a test position.The elongate member is advanced over the wire guide to place a distalend at or adjacent to the distal tip of the wire guide. The elongatemember emits illuminating light via the distal end of the elongatemember. The location of the light (e.g., the source) is viewed throughthe patient's skin to confirm the positioning (or confirm incorrectpositioning) of the wire guide.

In another embodiment of the invention, a method of confirming thelocation of the wire guide intended to be positioned within a patient'ssinus cavity includes introducing a wire guide through a nasalpassageway to place a distal tip of the wire guide in a test position,the wire guide including a detection element positioned at or adjacentto the distal tip of the wire guide. A detector device is then placedexternal to the patient's skin adjacent to the intended sinus cavity soas to detect the presence or absence of the detection element.

In still another aspect of the invention, a system for accessing a sinuscavity of a patient includes a trocar having an outer cannula and apiercing member slidably disposed within a lumen of the cannula. Thesystem includes an elongate member having an inflation member disposedthereon, the elongate member being slidably disposed within the lumen ofthe cannula.

In yet another aspect of the invention, a device for accessing the sinuscavity of a patient includes an outer cannula having a lumen and apiercing member slidably disposed within the lumen of the cannula. Anadjustable stop is secured to a distal portion of the piercing member.

In still another aspect of the invention, a device for accessing thesinus cavity of a patient includes an outer cannula having a lumen and apiercing member slidably disposed within the lumen of the cannula. Astop is secured to one of the outer cannula and the piercing member.

In another aspect of the invention, a device for accessing the sinuscavity of a patient includes an outer cannula having a lumen, a piercingmember slidably disposed within the lumen of the cannula, the piercingmember including a threaded portion on a proximal section of thepiercing member. The device further includes a threaded hub configuredto rotationally engage the threaded portion of the piercing member.

In still another aspect of the invention, a device for accessing thesinus cavity of a patient includes an outer cannula having a lumen, apiercing member slidably disposed within the lumen of the cannula, thepiercing member including a proximal section. The device furtherincludes an advancement member frictionally engaged with the proximalsection of the piercing member, wherein the advancement member controlsthe displacement of the piercing member relative to the outer cannula.

In yet another embodiment of the invention, a balloon catheter fortreating a constricted sinus passageway of a patient includes a flexibleelongate member having a proximal end and a distal end and includingfirst and second lumens passing therethrough. A hub is secured to aproximal end of the flexible elongate member, the hub including a firstport in communication with the first lumen of the flexible elongatemember and a second port in communication with the second lumen of theflexible elongate member. An inflation member is disposed on or adjacentto the distal end of the flexible elongate member, an interior of theinflation member being in communication with the first lumen of theflexible elongate member. An outer membrane surrounds the inflationmember, an interior of the outer membrane being in communication withthe second lumen of the flexible elongate member, the outer membraneincluding a plurality of perforations.

In still another embodiment of the invention, a stabilizing device forsecuring one or more tools passing into a nasal or sinus cavity of apatient includes a base member fixedly secured to the face of thepatient, an adjustable support arm secured at a first end to the basemember, and a securing member fixed to a second end of the adjustablesupport arm, the securing member configured to releasable hold at leastone tool passing into the nasal or sinus cavity of a patient.

In another embodiment of the invention, a method of stabilizing one ormore tools passing into a nasal passage of a patient includes insertinga tool into the nasal passage of the patient. A stabilizing element isthen inserted into the nasal passage of the patient adjacent to thetool, the stabilizing element being inserted in a non expanded state.The stabilizing element is expanded to an expanded state to frictionallyengage the tool within the nasal passage of the patient.

In another embodiment of the invention, a stabilizing device forsecuring one or more tools passing into a sinus cavity of a patientincludes a mouth piece fixedly secured to the mouth of the patient, anadjustable support arm secured at a first end to the mouth piece, and asecuring member fixed to a second end of the adjustable support art, thesecuring member configured to releasably hold at least one tool passinginto the sinus cavity of a patient.

In still another aspect of the invention, a system for manipulating aguide catheter within a patient's nasal passages or sinus cavities isprovided. The system includes a guide catheter formed from an elongateflexible member having a lumen passing therethrough and a wire guideslidably disposed within the lumen of the guide catheter. The systemincludes a steering member fixedly secured to a proximal end of the wireguide and a proximal hub secured to a proximal end of the guidecatheter. The system further includes a recessed handle having a firstrecess for fixedly receiving the proximal hub of the guide catheter anda second recess for receiving the steering member, the second recessbeing dimensioned to permit axial and rotational movement of thesteering member while disposed in the second recess.

In yet another aspect of the invention, a system for manipulating aguide catheter within a patient's nasal passages or sinus cavities isprovided. The system includes a guide catheter formed from an elongateflexible member having a lumen passing therethrough, the guide catheterincluding a proximal handle including a recess therein. A wire guide isslidably disposed within the lumen of the guide catheter. The systemincludes a steering member fixedly secured to a proximal end of the wireguide and disposed in the recess of the handle, the recess beingdimensioned to permit axial and rotational movement of the steeringmember while disposed in the recess.

In another embodiment of the invention, a guide catheter for accessing asinus cavity of a patient includes an elongate member having a proximalend and distal end and at least one lumen passing therethrough, thedistal end including a flexible tip portion, the elongate member beingformed from a polymeric material containing a wire braid. The guidecatheter further includes a hub connected to the proximal end of theelongate member.

In still another aspect of the invention, a balloon catheter fortreating a constricted sinus passageway of a patient includes anelongate flexible shaft comprising an inner tube and an outer tube, theelongate flexible shaft having a proximal end and distal region, whereinat least one of the inner tube and outer tube is formed with akink-resistant coil in the distal region. A hub is affixed to a proximalend of the elongate flexible shaft, the hub including a port incommunication with a lumen formed between the inner tube and the outertube. An expandable member is disposed on a distal region of theelongate flexible shaft, an interior of the expandable member being incommunication with the lumen formed between the inner tube and the outertube.

In another embodiment of the invention, a guide catheter for guiding oneor more devices into an ostium of a paranasal sinus includes an elongateshaft defining a proximal region and a distal region, the elongate shaftincluding a lumen passing from the proximal region to the distal region.The elongate shaft includes a curved portion in the distal region, thecurved portion having a radius of curvature of between about 1 mm andabout 5 mm and an angle of between about 120° and about 180°.

In still another aspect of the invention, a method of placing a wireguide into the ostium of a paranasal sinus includes introducing adirectable endoscope into the nasal cavity. A guide catheter is insertedinto the nasal cavity to position a distal tip near the sinus ostium.The endoscope is manipulated to move the viewing field toward the sinusostium. A wire guide is inserted through a lumen in the guide catheterand the wire guide is manipulated to place the same at least partiallywithin or adjacent to the sinus ostium.

In another embodiment of the invention, a method of placing a wire guideinto the ostium of a paranasal sinus includes introducing a retrograderigid endoscope into the nasal cavity and introducing a guide catheterinto the nasal cavity to position a distal tip near the sinus ostium.The endoscope is oriented to move the viewing field toward the sinusostium. A wire guide is inserted through a lumen in the guide catheterand the wire guide is manipulated to place the wire guide at leastpartially within or adjacent to the sinus ostium.

In yet another embodiment of the invention, a method of placing a wireguide into the ostium of a paranasal sinus includes introducing a guidecatheter into the nasal cavity to position a distal tip near the sinusostium. A wire guide is inserted through a lumen in the guide catheterand the wire guide is manipulated to place the wire guide at leastpartially beyond a distal tip of the guide catheter. A flexiblevisualization scope is introduced over the wire guide to position aviewing field toward the sinus ostium. The wire guide is manipulated toplace the wire guide at least partially within the sinus ostium.

In still another aspect of the invention, a method of placing a wireguide into the ostium of a paranasal sinus includes introducing adirectable endoscope sheath into the nasal cavity, the endoscope sheathincluding at least one working lumen therein. The endoscope ismanipulated to move the viewing field toward the sinus ostium. A wireguide is inserted through the lumen in the endoscope sheath. The wireguide is manipulated to place the wire guide at least partially withinor adjacent to the sinus ostium.

In yet another aspect of the invention, a method of remodeling theuncinate process associated with a paranasal sinus includes positioningat least one shim member in the infundibulum, the shim member deformingthe uncinate process and widening at least a portion of theinfundibulum. The shim member may be permanent or biodegradable. Inaddition, multiple shims may be positioned within the infandibulum. Theat least one shim members may be delivered using a delivery tool. Forexample, the at least one shim member may be inserted into theinfandibulum in a first orientation and then rotated into position. Theat least one shim member may include a gripping member (e.g., teeth) onan exterior surface thereof.

In another aspect of the invention, a device for remodeling the uncinateprocess associated with a paranasal sinus includes an elongate deliverytool and at least one shim member detachably mounted to a distal end ofthe elongate delivery tool. The elongate delivery tool may include atorque driver to transmit rotational movement of a proximal end torotational movement of a distal end. In one aspect, the at least oneshim member and the elongate delivery tool are slidably disposed withina guide catheter.

In another embodiment of the invention, a method of treating aconstricted sinus passageway of a patient includes traversing theexternal skull wall of the patient so as to form a passageway to thefrontal sinus cavity and inserting an elongate member through thepassageway, the elongate member having an inflation member disposedthereon. The inflation member is positioned within the constricted sinuspassageway and the inflation member is expanded so as to expand at leasta portion of the constricted sinus passageway.

In still another embodiment of the invention, a device for accessing thesinus cavity of a patient includes an outer cannula having a lumen, theouter cannula having a flexible curved tip. The device further includesa piercing member slidably disposed within the lumen of the cannula, thepiercing member including a proximal section. An advancement member isfrictionally engaged with the proximal section of the piercing member.

In another aspect of the invention, a method of treating a constrictedsinus passageway in a frontal sinus of a patient includes forming anartificial passageway into the frontal sinus of the patient with a tool.An elongate member having an inflation member thereon is insertedthrough the passageway. The inflation member is positioned with theconstricted sinus passageway and the inflation member is expanded so asto expand at least a portion of the constricted sinus passageway.

Further features and advantages will become apparent upon review of thefollowing drawings and description of the preferred embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates is a schematic view illustrating the paranasalsinuses in relation to the face.

FIG. 2 is a coronal section of the human skull, showing the paranasalsinuses.

FIGS. 3A-3C are of a sagittal view of the lateral nasal wall,illustrating various anatomical features thereof.

FIG. 4 illustrates one embodiment of the current invention showing aballoon dilation catheter in the ostial region of a paranasal sinus.

FIG. 5A illustrates one embodiment of a guide catheter according to theinvention.

FIG. 5B is a cross-sectional view of the embodiment shown in FIG. 5A.

FIG. 5C is a cross-sectional view of an alternative embodiment of aguide catheter.

FIG. 5D is an alternative embodiment of a guide catheter.

FIG. 5E shows the guide catheter of the embodiment illustrated in FIG.5D being positioned within the nasal cavity.

FIG. 5F is a cross-sectional view of an alternative embodiment of aguide catheter.

FIG. 6A illustrates an embodiment of a balloon dilation catheteraccording to one embodiment of the invention.

FIG. 6B is a longitudinal sectional view of a portion of the distalshaft of the embodiment of FIG. 6A.

FIG. 6C is a cross-section of the distal shaft of the embodiment of FIG.6A.

FIG. 7A illustrates an alternative embodiment of a balloon dilationcatheter according to one embodiment.

FIG. 7B is a longitudinal sectional view of a portion of the distalshaft of the embodiment of FIG. 7A.

FIG. 7C is a cross-sectional view of the distal shaft of the embodimentof FIG. 7A.

FIG. 8 illustrates an embodiment of a stabilization device according toone aspect of the invention.

FIG. 9 illustrates an alternative embodiment of a stabilization deviceaccording to another aspect of the invention.

FIG. 10A illustrates a further alternative embodiment of a stabilizationdevice according to another aspect of the invention.

FIG. 10B is a partially exploded top view of the stabilization device ofFIG. 10A.

FIG. 10C is a partially exploded front view of the stabilization deviceof FIG. 10A.

FIG. 10D is an assembled front view of the stabilization device of FIG.10A.

FIG. 11A illustrates an embodiment of a wire movement guide according toone aspect of the invention.

FIG. 11B is a cross-sectional view of the wire movement guide of FIG.11A.

FIG. 11C is an assembly drawing of the wire movement guide of FIG. 11Aattached to a guide catheter.

FIG. 11D illustrates a method for placement of a wire guide in a sinusostium according to one aspect of the invention.

FIG. 12 illustrates a method and device for confirming the placement ofa wire guide in a sinus according to one aspect of the invention.

FIG. 13 illustrates an alternative method and device for confirming theplacement of a wire guide, according to another aspect of the invention.

FIG. 14 illustrates methods and devices for accessing a sinus accordingto one aspect of the invention.

FIG. 15 shows additional methods and devices for accessing a sinus,according to another aspect of the invention.

FIG. 16A shows additional methods and devices for accessing a sinusaccording to another aspect of the invention.

FIG. 16B shows a flexible visualization scope as used in connection withFIG. 16A.

FIG. 16C is a cross-sectional view of the flexible visualization scopeof FIG. 16B.

FIG. 17A shows additional methods and devices for accessing a sinusaccording to one of the invention.

FIG. 17B shows an embodiment of a directable endoscope sheath as used inconnection with FIG. 17A.

FIG. 17C is a cross-sectional view of the directable endoscope sheath ofFIG. 17B.

FIG. 18A illustrates methods and devices for accessing a sinus from anexternal location according to one aspect of the invention.

FIG. 18B illustrates additional methods and devices for accessing asinus ostium from an external location according to one aspect of theinvention.

FIG. 18C illustrates further additional methods and devices foraccessing a sinus ostium from an external location according to anotheraspect of the invention.

FIGS. 19A-19C are cross-sectional images depicting various arrangementsof devices used in accessing a sinus ostium in connection with FIG. 18B.

FIG. 20 illustrates methods and devices for treating a sinus ostium inone aspect of the invention.

FIG. 21 shows an embodiment of a trocar in accordance with one aspect ofthe invention.

FIG. 22 shows another embodiment of a trocar according to another aspectof the invention.

FIGS. 23A and 23B show additional methods and devices for accessing asinus ostium from an external location according to one aspect of theinvention.

FIG. 24 shows additional methods and devices for accessing a sinusostium from an external location according to another aspect of theinvention.

FIG. 25A is a coronal view showing anatomical features of the maxillarysinus.

FIG. 25B is a sagittal view showing the anatomical features of FIG. 25A.

FIG. 26A is a coronal view illustrating methods and devices for thetreatment of the uncinate process in accordance with one aspect of theinvention.

FIG. 26B is a sagittal view illustrating methods and devices for thetreatment of the uncinate process in accordance with one aspect of theinvention.

FIG. 27A is a top view of an embodiment of a shim member in accordancewith one aspect of the invention.

FIG. 27B is an isometric view of the shim member of FIG. 27A.

FIG. 28 is an embodiment of a shim member delivery device in accordancewith one aspect of the invention.

FIG. 29 illustrates a method and device for widening the infundibulum inaccordance with another aspect of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 illustrates a frontal anatomical representation (parallel to thecoronal plane) showing the sinuses FS, ES, MS located within a patient'shead H. Above and behind the eyebrows are the frontal sinuses FS.Between the eyes are the ethmoid sinuses ES. Note that unlike the othersinuses, the ethmoids are typically formed as a “honeycombed” structureconsisting of several individual air cells. Located behind the cheeksare the maxillary sinuses MS. The sphenoid sinuses are not shown in FIG.1, but are located further posterior to the ethmoid sinuses.

FIG. 2 is another frontal view of the sinuses located within the skullbone SK showing additional features. The nasal septum NS divides thenasal cavity into left and right sides. Because the following describedstructures are generally symmetrical bilaterally, only one of the pairedstructures is illustrated for sake of convenience. Within the nasalcavity are the middle turbinate MT and the inferior turbinate IT. Themiddle turbinate MT is connected to the base of the skull SK, while theinferior turbinate IT is connected to the lateral wall of the sinuscavity. The turbinates MT, IT have an underlying bony structure, but arecovered with a thick mucosa lining. When this lining swells (rhinitis),it can inhibit breathing through the nose, particularly the inferiorturbinate IT. The ethmoid sinuses ES are depicted by a single air cellin FIG. 2. The uncinate process UP is a complex three-dimensionalstructure, projecting off of the lateral wall like a crescent shapedleaf (better seen in FIGS. 3B and 25B) The curved aspect of the medialbone defining the ethmoid sinuses ES is called the ethmoid bulla EB. Thepassageway between the ethmoid bulla EB and the uncinate process UP isreferred to as the infundibulum I. The drainage path of the maxillaryMS, frontal FS, and some of the ethmoid ES air cells runs into theinfundibulum I. At the most inferior part of the maxillary sinus is athin portion of skull bone referred to as the canine fossa CF. Thoughthis is not a true opening, it is a relatively thin bone region, justabove the root of the outer aspect of the canine teeth, inside themouth. The relationship of the sinuses to the orbit O of the eye canalso be seen. Note also that all of the sinus cavities have a mucosalining (ML) disposed over the bone.

FIG. 3A is a side view parallel to the sagittal plane, looking at theright lateral nasal wall. The right nostril N is seen. The sphenoidsinus SS and frontal sinus FS may also be seen in this view. Theflap-like structures illustrated in FIG. 3A are the inferior turbinateIT and middle turbinate MT. Other structures of the nasal cavity havebeen left out for clarification, e.g., the superior turbinate. Locatedunderneath the middle turbinate MT (shown in a “lifted” state in FIG. 3Band removed in FIG. 25B) are the structures of the lateral nasal wall.As seen in FIG. 3B, the ethmoid bulla EB is a rounded projection of thebony wall of the nasal cavity. Behind the wall of the ethmoid bulla EBare one or more of the individual air cells of the ethmoid sinus ES (notshown in FIGS. 3B and 25B). Anterior and inferior of the ethmoid bullais the uncinate process UP. The uncinate process UP has essentially twoedges to it including a free edge FE and a connected edge CE. The freeedge FE stands out from the nasal wall, while the connected edge CEconnects the structure to the nasal wall. The narrow space between theethmoid bulla EB and the uncinate process UP is the infundibulum I.Thus, it can be appreciated the complexity of the anatomy involving themaxillary and ethmoid sinus structures MS, ES.

FIG. 3C illustrates the structure beneath or underneath the uncinateprocess UP. In FIG. 3C, the uncinate process UP has been removed forclarity purposes, leaving only the connected edge CE. Two ostia can beseen including the maxillary sinus ostium MO, and the frontal sinusostium FO. Drainage from the frontal sinuses FS and maxillary sinuses MSemerges into the infundibulum I through the maxillary sinus ostium MOand the frontal sinus ostium FO. Also, some of the ethmoid air cells ESdrain into the infundibulum I, but they are not shown as they aresubstantially smaller than the frontal and maxillary ostia FO, MO.Drainage problems can arise and/or extend from the ostia of one or moreof these sinuses to the infundibulum I or vise versa. Consequently,conventional FESS surgical treatment of sinusitis typically involveswidening one or more of the ostia FO, MO, as well as complete removal ofthe uncinate process UP. Incidentally, removal of the uncinate processUP is usually required even to just allow visualization of these sinusostia FO, MO for the proper placement of the various surgical cuttinginstruments. Ethmoids are often treated with the FESS procedure byremoving some of the wall of the ethmoid bulla EB and some of the“honeycomb” structure between the individual air cells.

FIG. 4 illustrates a generic therapeutic approach contemplated by oneembodiment of the invention. Rather than remove obstructing tissueassociated with the sinus ostia FO, MO, a dilation balloon 10 ispositioned in the narrowed region to dilate open the structure.Generally, the dilation balloon is carried on a distal end or region ofelongate member 12 such as a balloon catheter. The balloon catheter 12may include a proximal hub 14 that includes an inflation port 16 that isused inflate (and deflate) the dilation balloon 10. For example, theinflation port 16 may connect to a syringe or the like (not shown)using, for instance, a Leur lock connection. The balloon catheter 12 maybe disposed within a central lumen of a guide catheter 18. The guidecatheter 18 may include a flexible tip portion 18 b as well as a curvedportion 20 that is used to navigate the tortuous pathway around theuncinate process UP. The proximal end of the guide catheter 18 mayinclude a hub 22.

Still referring to FIG. 4, a wire guide 24 is located within a centrallumen in the balloon catheter 12. The wire guide 24 in FIG. 4 isintroduced into the maxillary sinus MS with the aid of the guidecatheter 18 and a steering device 26. The wire guide 24 preferably has acurved tip 24 b such as a “J” bend located at or adjacent to a distaltip 24 a of the wire guide 24. The steering device 26 connects to aproximal end of the wire guide 24 to allow rotation of the wire guide24, and subsequent rotation of the curved tip 24 b to steer and directthe wire guide 24. As can be seen in FIG. 4, there is a relatively sharpbend that the wire guide 24 and balloon catheter 12 must traverse toenter into the maxillary ostial MO region. It is contemplated that aguide catheter 18 may not be utilized at the time that the ballooncatheter 12 is positioned in the ostium of interest, but rather theguide catheter 18 would be utilized just for placement of the wire guide24. In this case, the balloon catheter 12 would be advanced over thewire guide 24. This helps to minimize the size of the “hardware” that ispresent in the nasal cavity at any one time by allowing use of a smallerdiameter guide catheter 18, and minimizes the amount of distortionrequired on various structures in the nasal cavity, such as the middleturbinate MT.

Still referring to FIG. 4, dilation of the maxillary ostial MO region isaccomplished by inflation of the balloon 10 via the inflation port 16with an inflation apparatus (not shown) which may included, for example,a syringe. It is contemplated that a combination of remodeling the softtissues as well as fracturing/crushing bony tissues will result in amore open drainage path for the sinus(es) being treated. While FIG. 4shows a balloon catheter 12 positioned in the maxillary sinus ostium(MO), it is contemplated that the balloon 10 could be positioned in anyof the sinus ostia, either naturally occurring ostia, or ostia createdintra-procedurally. In particular, treatment of the ethmoid air cells ESmay be accomplished by creating one or more small passageways in thewalls surrounding the air cells, for example with a needle, followed upby a dilation process using the dilation balloon catheter 12. Moreover,reference to a particular ostium does not necessarily mean an opening orpassageway per se. Rather, reference to ostium may include the generalregion or anatomical area surrounding or adjacent to the ostium ofinterest and is not limited to a single, discrete structure or location.

Access to the maxillary sinus ostium MO from within the nasal cavity isparticularly challenging due in part to the anatomy of the uncinateprocess UP and infundibulum I. FIGS. 5A and 5B illustrate variousembodiments of a guide catheter 18 used to facilitate access to themaxillary sinus from the nasal cavity. In FIG. 5A, the guide catheter 18has a relatively tight curved portion 20 near the tip 18 b, with apreferred inside radius of curvature between about 0.5 mm and about 10mm, and more preferably between about 1 mm and about 5 mm. Such a radiusof curvature will assist in the tip 18 b of the guide catheter “hooking”around the uncinate process UP, to help direct the wire guide 24 andsubsequently the balloon catheter 12 into the maxillary sinus ostium MO.The degree of bend of the curved portion of the guide catheter 18 ispreferably between 90 degrees and 180 degrees from the longitudinal axisof the hub 22, and more preferably between 120 and 160 degrees.

In one preferred aspect of the invention, the guide catheter 18 includesa shaft portion 18 a and a flexible tip portion 18 b. The tip portion 18b is preferably of a softer material than the shaft portion 18 a. Tipportion 18 b may formed of a polymer such as PEBAX (Arkema),polyurethane, NYLON (DuPont), HYTREL (DuPont), or silicone. FIG. 5Billustrates a cross-sectional view of one preferred embodiment of theshaft portion 18 b. As seen in FIG. 5B, a liner 34 of a lubriciousmaterial such as PTFE defines a central lumen 36. The liner 34 issurrounded by a wire braid 32. The wire braid 32 is encased in apolymeric material such as PEBAX (Arkema), polyurethane (DuPont), NYLON(DuPont), HYTREL (DuPont), or silicone. The wire braid 32 adds torsionalstrength to the shaft 18, allowing the curved tip portion 18 b to becontrolled and directed by manipulations near the hub 22. The tipportion 18 b may be pre-formed by a suitable process such as heatforming.

Alternatively, as shown in 5C, the guide catheter 18 shaft portion 18 aand/or tip portion 18 b may incorporate a shaping element 38, such as aremovable wire. The wire 38 is preferably axially slidable within alumen 40 formed in the guide catheter 18. For example, differentpre-shaped wires 38 may be axially slid within the lumen 40 to impartthe desired shape or bend in the guide catheter 18. Alternatively,shaping element 38 could be a ductile non-removable wire that could beshaped and re-shaped to fit to a particular patient's anatomy. Thisfeature advantageously allows the tip curvature or the curvature of anyportion of the guide catheter 18 to be customized by the user prior toor during a procedure.

Alternatively, the shaft portion 18 b of the guide catheter 18 can beformed of a metallic tube rather than the braid and jacket construction.This embodiment is illustrated in FIG. 5F. Preferably a liner 34 isinside the metallic tube. Such a construction would allow the shaftportion 18 b to be shaped and reshaped to suit any particular anatomy.

The diameter of the guide catheter 18 is determined by the size of thedevices that might pass through it. For example, if the guide catheter18 is used only for the placement of a wire guide 24 of 0.014 inchdiameter, then the guide catheter 18 may have an inner diameter ofbetween 0.016 and 0.025 inches, and a total wall thickness of between0.004 and 0.020 inches. However if the guide catheter 18 is used toassist in placement of a dilation balloon catheter 12, the innerdiameter is preferably between 0.040 and 0.100 inches, with a total wallthickness of between 0.005 and 0.030 inches. The outer diameter of theguide catheter shaft 18 a and tip 18 b is preferably uniform indiameter. The length of the guide catheter 18 is preferably betweenabout 8 and about 25 cm, and more preferably between about 10 and about20 cm.

FIG. 5D illustrates another embodiment of a guide catheter 18 that isparticularly useful for cannulating the maxillary sinus ostium MO. Inthis embodiment, the curved portion 42 is of a substantially largerradius of curvature compared to the embodiment shown in FIG. 5A. Ratherthan take a “direct” path up to and around the uncinate process UP, theembodiment shown in FIG. 5D makes use of the significantanterior-posterior space in the nasal passage NP. The curvature 42 ofthe guide catheter 18 may be formed using a shaping element 38 of thetype disclosed in FIG. 5C.

FIG. 5E illustrates how the guide catheter 18 shown in FIG. 5D makes amore gradual sweeping turn in the nasal cavity to reach towards themaxillary sinus ostium MO. By possessing a larger radius of curvature,any devices used inside this guide catheter 18 are not forced tonegotiate such a tight bend. In a preferred embodiment, the insideradius of curvature is preferably between about 1 cm and about 3 cm, andmore preferably between about 1.5 and about 2.5 cm.

FIGS. 6A, 6B, and 6C show a preferred embodiment of a dilation ballooncatheter 12 for dilation of a sinus ostium, particularly a maxillarysinus ostium MO. The balloon catheter 12 includes a balloon 10, distalshaft portion 12 a, proximal shaft portion 12 b, and a hub 14 with aninflation port 16 for inflation of the balloon 10. The balloon catheter12 is formed using an inner tube 50 coaxially arranged within an outertube 52 (described in more detail below). An inflation lumen 56 isformed between the inner tube 50 and the outer tube 52. The ballooncatheter 12 terminates at a distal tip 12 c that projects distally fromthe balloon 10. The balloon catheter 12 may be formed as an “over thewire” design (as shown in FIGS. 6A-6C), but it is contemplated that itcould be a “fixed wire” design or a “monorail” design, as is known inthe balloon catheter art, particularly the coronary angioplasty art.However, the length of the balloon catheter 12 shown is relatively shortin comparison, preferably from about 10 to about 30 cm, and morepreferably between about 15 and about 25 cm. The expanded diameter ofthe balloon 10 would depend on the initial and final desired size of thesinus ostium to be dilated. Preferred diameters would be from about 2 mmto about 10 mm, and most preferably from about 3 to about 7 mm. Apreferred “set” of balloon catheters 12 would include a series ofcatheters having inflated balloon diameters of 2, 4, 6, and 8 mm.Alternatively, a series of catheters 12 having 3, 5, and, 7 mm expandedballoon diameters could be provided. The balloon 10 is preferably fromabout 5 mm to 40 mm in length (not including the conical portions), andmore preferably from about 10 mm to about 20 mm in length.

With particular reference to FIG. 6B, the distal shaft portion 12 a ofthe balloon catheter 12 is preferably of a coaxial construction, with aninner tube 50 located inside of an outer tube 52. The inner tube definesthe wire guide lumen 54 for passage of the wire guide 24 (not shown inFIG. 6B). The annular space formed between the inner and outer tubes 50,52 defines an inflation lumen 56. The inflation lumen 56 may hold afluid which is used to inflate the balloon 10. In the embodiment of FIG.6B, lumens 54, 56 are coaxially arranged. However it is contemplatedthat a single tube with two side-by-side lumens 54, 56 could be utilizedas well.

Because of the anatomic challenge of accessing the maxillary sinusostium MO, a preferred embodiment of the balloon catheter 12 includes akink-resisting structure in the shaft, particularly in the distal shaftportion 12 a, as this is the portion of the catheter 12 that may beexposed to a particularly tight bend as it is advanced around theuncinate process UP. The kink resisting structure is preferably a coil58, 60 or braid (not shown) that is incorporated into the inner tube 50and/or the outer tube 52. FIG. 6B illustrates coils 58, 60 incorporatedin both the inner and outer tubes 50 52, respectively. If a coil 58 isincorporated in the inner tube 50, it is preferably included in theentire distal portion 12 a, including that portion that traverses theballoon 10. It is contemplated that for other constructions such as“fixed wire” or “rapid exchange” that the kink resisting structure couldalso be incorporated.

Inner and outer tubes 50, 52 are preferably formed of a suitablematerial such as polyethylene, PEBAX (Arkema), PTFE, NYLON (DuPont),HYTREL (DuPont), or a combination thereof. Proximal shaft portion 12 bmay be more rigid than distal portion 12 b, and may further incorporatea metallic tube (not shown) for either the inner tube 50 or the outertube 52 of the proximal shaft region.

To assist in positioning of the balloon catheter 12 to a target site,one or more shaft markers 62 may be provided at one or more locationsalong the shaft of the balloon catheter. Preferably, the markers 62 arepositioned in uniform increments (e.g., 1 cm increments) along the fulllength of the shaft (proximal region 12 b and distal region 12 a).Additionally, one or more markers 64 on the balloon 10 may be provided.Both the shaft markers 62 and the balloon markers 64 are useful inpositioning the balloon 10 relative to the wire guide 24 and/or guidecatheter 18, together with prior or continuous optical visualizationusing a visualization tool such as an endoscope. Although not shown, thewire guide 24 could also include markers spaced at predefinedincrements. Balloon markers 64, shaft markers 62, and/or wire guidemarkers (not shown) could make use of a color-coding system or someother recognizable pattern to facilitate endoscopic imaging. Forinstance, a certain color of marker could pertain to a certain distancefrom a particular location, such as the tip of the wire guide 24 or thecenter of the dilation balloon 10. Alternatively, one or more radiopaquemarkers (not shown) could be provided on the shaft underneath theballoon 10 if fluoroscopic imaging is utilized.

FIGS. 7A, 7B, and 7C show an alternative embodiment for a sinus ostiumdilation balloon catheter 12. In addition to the structures associatedwith the catheter shown in FIGS. 6A and 6B, this embodiment furtherincorporates structure to facilitate the infusion and delivery of one ormore therapeutic and/or diagnostic agents at the site of the dilationballoon 10. In a preferred embodiment, a portion of the balloon catheter12 that extends proximally and distally with respect to the balloon 10includes an outer membrane 70 with one or more perforations 72 in themembrane wall. The space between the balloon 10 and the membrane 70 isin fluid communication with an infusion lumen 74 (shown in FIG. 7B)formed in the shaft of the balloon catheter 12. The infusion lumen 74could be formed by the addition of an infusion tube 76 located on theoutside of the outer tube 52. An infusion port 76 located in theproximal hub 14 is in fluid communication with the infusion lumen 74.

The balloon catheter 12 illustrated in FIGS. 7A-7C may be particularlyuseful for the delivery of an adhesion preventing substance such asMeroGel (Medtronic/Xomed) or Sepragel® (Genzyme Biosurgical/Gyrus ENT)prior to, during, or following the dilation process. This would resultin a coating or “sleeve” of the agent being disposed on the contactedtissue region. The fact that the coating or “sleeve” would have an openpassageway would provide for immediate ventilation and drainage of thetreated sinus.

FIGS. 8, 9, and 10 shows various embodiments of a stabilizing device 80for use with the device and methods disclosed herein. The stabilizingdevice 80 is used to assist in holding and stabilizing one or more ofthe various tools used in the treatment of a sinus ostium. Since attimes many devices may be in use, it may be difficult for the physicianto manage all such devices. Use of a stabilizing device can free thehands to manage fewer devices at any given time. For example, thestabilizing device 80 may be used to stabilize a guide catheter 18 (asshown in FIG. 8), a balloon catheter 12, and/or an endoscope 82.

The embodiment shown in FIG. 8 utilizes a base member 84 which securesto various portions of the head H, such as the ears and/or top of thenose. Preferably, two ear hooks 86 wrap around the ear in a similar wayas eyeglasses. The base member 84 also rests on the nose with a nosebridge 88. A support arm 90 is secured to the base member 84. In oneaspect of the invention, the support arm 90, can preferably bemanipulated or formed into any desired shape. For example, the supportarm 90 may be formed from a flexible material. A securing member 92 suchas a clamp is located on the free end of the support arm 90. Thesecuring member 92 may be removable and/or interchangeable via atightening member. Support arm 90 and securing member 92 are held fastby a tightening member 94 such as a tightening nut. In this figure, aclamp 92 is shown stabilizing a guide catheter 18, which allows thephysician to use his or her hands on the endoscope 82 and the wire guide24, while the position of the guide catheter 18 is maintained. This maybe helpful while the physician tries to advance the wire guide 24 intothe desired sinus. It is contemplated that more than one securing member92 and/or more than one support arm 90 could be mounted to the basemember 84 to stabilize more than one device.

The embodiment illustrated in FIG. 9, a stabilizing element 100stabilizes a device against an interior surface of the nostril. As shownin FIG. 9, the stabilizing element is stabilizing a guide catheter 18.In one preferred embodiment, the stabilizing element 100 is formed as anexpandable tubular structure, such as a self-expanding tubular braid. Inthe expanded state, the tubular structure includes a lumen or passagewaythrough which one or more devices may be placed. The expandable tube 100is positioned in the nostril next to the device(s) to be stabilized.Friction holds the device(s) in place, while maintaining a passagewayfor additional devices such as an endoscope (not shown in FIG. 9) to beintroduced into the nasal cavity. More than one expandable tube 100could be used, either next to another, or in a nesting relationship.

With reference now to FIGS. 10A, 10B, 10C, and 10D, a stabilizing device110 makes use of the patient's mouth M. A mouth piece 112 is connectedcoupled to a support arm 114, which is connected to a securing member116 such as a clamp to stabilize the position of a device such as aguide catheter 18. The support arm 114 and clamp 116 can be positioned,e.g. by rotating around pivot points, to bring the clamp 116 to anydesired position. FIG. 10B shows a top view of the stabilizing device110 in a partially exploded view. The mouth piece 112 is configured toengage the upper and/or lower jaw of the patient. The support arm 114 isconnected to the mouth piece 112, preferably by a lockable pivot point118. The clamp 116 is likewise connected to the support arm 114. Aseries of securing members 120 such as locking screws or nuts locks theclamp 116 position relative to the mouth M.

FIG. 10C is a partially exploded frontal view of the stabilizing device110 of FIG. 10B. FIG. 10D shows the stabilizing 110 device in the fullyassembled state. Again, one or more support arms and/or one or moreclamps 116 could be used to stabilize multiple devices such as guidecatheters 18, wire guides 24, endoscopes 82, or other instruments usedby the physician.

FIGS. 11A, 11B, and 11C illustrate a wire movement guide 130 that isused to facilitate one-handed movement of both the wire guide 24 andguide catheter 18. The wire movement guide 130 may be formed as arecessed handle or the like. As seen in FIG. 11C, during operation ofthe guide catheter 18, a steering device 26 is secured to the wire guide24. The steering device 26 is able to slide axially and rotate in themovement path (as shown by arrows A and B in FIG. 11C). In a preferredembodiment, the recessed handle 130 includes a hub recess 132 that issized to receive the hub 22 of the guide catheter 18. For example, thehub recess 132 may be sized to frictionally secure the hub 22 within thesame. Alternatively, one or more detents, tabs, or the like may bepositioned on the hub recess 132 and/or hub 22 to releasably secure wiremovement guide to the hub 22 of the guide catheter 18. The wire movementguide 130 also includes a recess 134 for receiving the steering device26. The recess 134 is dimensioned to permit axial and rotationalmovement of the steering device 26 as is shown in FIG. 11C. The wiremovement guide 130 may also include a wire recess 136 for receiving thewire guide 24. The wire recess 136 may be interposed between the tworecesses 132, 134. In addition, a wire recess 136 may be located at aproximal end of the wire movement guide 130 to permit the wire guide 24to exit the proximal end of the wire movement guide 130. FIG. 11Billustrates a cross-sectional view of the wire movement guide 130.

In an alternative aspect of the invention, the wire movement guide 130could be formed integrally with the hub 22 or simply formed integrallyon the proximal end of the guide catheter 18.

With the use of a wire movement guide 130, the physician can move theguide catheter 18 into a desired position (preferably with the use ofendoscopic imaging, as depicted in FIG. 11D), while simultaneouslyadvancing and/or rotating the wire guide 24 with a single hand. Forexample, the fingers could be manipulating the wire movement guide 130and therefore the guide catheter 18, while the thumb is able tomanipulate the wire guide 24 to a desired position in the nasal cavityor sinus. A portion of the exterior surface of the steering device 26may be scored, roughened, or otherwise textured to aid the physician inmanipulating the steering device 26. The wire movement guide 130advantageously permits the physician to use his or her other hand toindependently manipulate another tool such as, for example, an endoscope82.

One preferred embodiment for positioning a wire guide 24 into themaxillary sinus ostium MO is depicted in FIG. 11D. In this embodiment,the guide catheter 18, wire movement guide 130, and wire guide 24 aremanipulated under endoscopic visualization. Here, the endoscope 82 is a“rigid” endoscope, a standard tool in nasal surgery. The rigid endoscopegenerally has a forward looking viewing field a which may or may not beoffset, a light port 82 a, and a viewing port 82 b through which animage is obtained (indicated with an eyeball symbol). The endoscope 82is used to help identify the uncinate process UP, and the guide catheter18 is “hooked” around the uncinate process UP. Additional tools such asa sinus “seeker” (not shown) can be utilized to help pull the uncinateprocess UP away from the opposite wall and make room for the tip 18 b ofthe guide catheter 18. Once the guide catheter tip 18 b is positioned,the wire guide 24 is manipulated by tactile feedback until it is felt tohave passed into the maxillary sinus ostium MO and into the maxillarysinus MS. FIG. 11D illustrates a simplified obstruction 138 locatedadjacent the uncinate process UP and maxillary sinus ostium MO. Thisobstruction 138 may include mucous, inflamed mucosa, scar tissue,abnormal bony structure, or other substances. In this manner, onlyconventional endoscopic imaging is utilized—without the need forfluoroscopic imaging and/or other specialized “image guidance”technology. This same technique could be utilized for the other sinusesand their ostia as well. In addition, one or more of the stabilizationdevices 80, 100, 110 previously described could be utilized as would beuseful in this or any of the subsequently described methods.

During operation of the device, it may be desirable to have a way toindependently confirm that the distal tip 24 a of the wire guide 24 hasbeen positioned in the desired sinus, and not inadvertently passedthrough some other structure, such as the orbital wall. Since thesinuses are difficult if not impossible to image with the standard rigidendoscopes, endoscopic imaging is not readily amenable for thisconfirmation. One such confirmation approach is illustrated in FIG. 12.As seen in FIG. 12, after the wire guide 24 has been positioned in whatis believed to be the desired location (maxillary sinus MS), a fiberoptic catheter 140 is positioned over the wire guide 24 and advanceddistally towards the tip of the wire guide 24. The fiber optic catheter140 may be positioned using a guide catheter 18 of the type illustratedin FIG. 12. The distal tip 140 a of the fiber optic catheter 140 emitslight 142 that is input into the fiber optic catheter 140 via a lightport 144. In one aspect of the invention, the emitted light 142 isbright enough such that it lights up or illuminates the sinus cavity andcan be visualized externally. In this regard, the surroundingenvironment (e.g., physicians office) may need to have the level ofambient light reduced or turned off completely to aid in thevisualization process.

If a structure other than the desired sinus is illuminated, thephysician or other operator knows that the wire guide 24 has beenimproperly positioned and can subsequently be repositioned into theproper location. Once the position of the wire guide 24 has beenconfirmed to be in the desired position, a balloon catheter 12 can thenbe confidently placed into the sinus ostium (e.g., MO) and dilated.

FIG. 13 illustrates an alternative embodiment for confirming theposition of a wire guide 24. In this embodiment, the wire guide 24 isfitted with a detection element 150 at or near the distal tip 24 a. Inone aspect, the detection element 150 can be made of a magneticmaterial. A magnetic detection device (not shown) which could be assimple as a floating magnetic needle such as a compass needle may thenbe positioned outside the patient's face near the sinus to confirm theposition of the wire tip 24 a. For example, in this case, the deflectionof the magnetic needle would indicate the presence of the detectionelement 150 (and thus the distal tip 24 a of the wire guide 24) withinthe desired sinus cavity.

Alternatively, the detection element 150 could be formed from a densemetallic material that can be detected with a metal detector device (notshown). For example, the metal detector device may include a probe orthe like that can be manipulated near to patient's face near the sinuscavity of interest to detect the presence (or absence) of the metallicdetection element 150. In yet another aspect, the detection element 150may emit a signal (e.g., radiofrequency pulse or the like) that can thenbe detected externally to confirm the presence or absence of the distaltip 24 a of the wire guide 24 within the sinus cavity of interest.

Independent confirmation methods and devices as described above may notbe necessary if more versatile optical imaging techniques and devicesare utilized in the placement of the various devices such as wire guides24, guide catheters 18, and/or balloon catheters 12. For instance, FIG.14 illustrates a method for placing a wire guide 24 across a sinusostium (e.g., maxillary ostium MO) with the aid of a directable orsteerable endoscope 152. Directable endoscopes 152 make use of flexiblefiber optic bundles which can be bent or curved to alter the directionof the viewing field 154. A typical construction of a directableendoscope 152 includes multiple control wires (not shown) connected nearthe distal tip 152 a and to a deflection knob 155. In this method, thedirectable endoscope 152 is positioned superior to the uncinate processUP and then directed retrograde to allow direct viewing of the viewingfield 154 where the guide catheter 18 and wire guide 24 are beingmanipulated. To further aid in the identification of the maxillary sinusostium MO, particularly in the case of occlusion 156 associated withsinusitis, the maxillary sinus MO is illuminated with the placement of asmall illumination member 158 into the sinus. The illumination member158 may be formed as an elongate member having a light-emitting distalend 158 a and a proximal end 158 b that is typically connected orotherwise coupled to a light source 160. In one aspect, the illuminationmember 158 is formed as a fiber optic light based device.

The illumination member 158 can be placed into the sinus cavity ofinterest (e.g., maxillary sinus MS) by using a piercing member 162 suchas, for example, an introducer needle 162 that is introduced through thecanine fossa CF region. It should be understood that reference to thecanine fossa CF refers to the general region or anatomical areasurrounding or adjacent to the canine fossa CF and is not limited to asingle, discrete structure or location. The introducer needle 162 mayinclude a hollow lumen or the like to permit the passage of theillumination member 158. The canine fossa CF is a thin portion of themaxillary sinus wall located adjacent the root of the canine teeth. Thecanine fossa CF has been utilized for other intrasinus procedures. Afterthe formation of a passageway 164 through the canine fossa CF, theillumination member 158 is advanced distally such that the distal tip158 a of the illumination member 158 is disposed inside the sinuscavity. The emitted light 162 in the maxillary sinus MS (or other sinuscavity) will be visible through the blockage 156 of the ostium MO usingthe directable endoscope 152. This aids the physician or other user todirect the wire guide 24.

FIG. 15 illustrates a similar method to FIG. 14, the difference beingthe use of a rigid retrograde endoscope 170. A rigid retrogradeendoscope 170 is similar to a normal rigid endoscope, but the directionof viewing field 172 is in a retrograde direction. The rigid retrogradeendoscope 170 has a substantially rigid shaft portion 173 and aretrograde viewing window 174 located at or near the distal tip 170 a.Retrograde visualization is accomplished through the use of one or moremirrors and/or lenses located at or adjacent to the viewing window 174to deflect the viewing field 172. Since the viewing field 172 isretrograde, this endoscope 170 can assist in accessing the sinus ostiumin a similar manner as described with respect to the method shown inFIG. 14. One difficulty with a rigid retrograde endoscope 170 is that itcan be awkward to initially position it, since it cannot be used to seestraight ahead. However, this difficulty is overcome by utilizing anormal rigid endoscope (not shown) alongside the retrograde rigidendoscope 170 to get it positioned initially in the nasal cavity. Again,an illumination member 158 in the sinus, placed via the canine fossa CF,can be further utilized to aid in accessing the sinus ostium.

Still other alternative methods for accessing the sinus ostium areillustrated in FIGS. 16A, 16B, and 16C. In these embodiments, a flexiblevisualization scope 180 is utilized. The flexible visualization scope180 includes an elongate flexible body 182 that contains a flexiblefiber optic bundle 183 (as shown in FIG. 16C) for viewing around bends.Although not shown in the figures, the fiber optic bundle 183 includesboth “imaging” fibers and “illumination” fibers for lighting up theviewing field 184. The flexible visualization scope 180 is notdirectable like the endoscope 152 of FIG. 14. Rather, the flexiblevisualization scope 180 includes a lumen or passageway 185 for the wireguide 24 and follows the wire guide 24 around bends as illustrated inFIG. 16A. Consequently, in this method, particularly for a maxillarysinus ostium MO, a guide catheter 18 having a curved distal portion 20is positioned near or around the uncinate process UP. A conventionalrigid endoscope (not shown) may be used to assist in this positioning.Next, the wire guide 24 is positioned near the tip 18 b of the guidecatheter 18. Then the flexible visualization scope 180 is advanced overthe wire guide 24, curving back in a retrograde fashion, allowing theviewing field 184 to be directed towards the sinus ostium (MO in thiscase). A blockage is shown 186 positioned within the maxillary ostiumMO. The wire guide 24 and guide catheter 18 may then be manipulatedunder visual observation to access the ostium MO. Again, as has beenmentioned previously, additional tools or the use of a “seeker” can beused in addition to the visualization scope 180, guide catheter 18 andwire guide 24. In addition, the sinus cavity of interest may beilluminated using the canine fossa CF access method described above withrespect to FIGS. 14 and 15.

Another alternative device and method for accessing a sinus ostium isillustrated in FIGS. 17A, 17B, and 17C. In this embodiment, a directableendoscope sheath 190 is provided that has a deflectable tip 190 a. Thedirectable endoscope sheath 190 is similar to the directable endoscope152 of FIG. 14, but further includes a working channel or lumen 192, asbest seen in FIG. 16C, together with the deflection wires 194 andoptical fibers 196 (which contain both imaging and illuminating fibers).In use, the directable endoscope sheath 190 can be introduced into thenasal cavity relatively straight, so as to see straight ahead. When thedirectable endoscope sheath 192 is near the uncinate process UP, the tip190 a is deflected retrograde using, for instance, a deflection knob197, so that the viewing field 198 is directed towards the sinus ostiumMO which contains an obstruction 200. At this point, a wire guide 24 ispositioned in the working lumen 192 and the ostium MO is accessed undervisual observation.

In one preferred embodiment, the directable endoscope sheath 190 has alarge enough working channel 192 that a balloon catheter 12 can beadvanced into the sheath 190 over the wire 24. In this manner, aseparate guide catheter 18 is not necessary. In yet another preferredembodiment, the working channel 192 is only large enough to accommodatethe wire guide 24. This allows for the sheath 190 to have a reasonablysmall outer diameter. Once the wire 24 is positioned in the sinus, thedirectable endoscope sheath 190 is removed from the wire 24, leaving thewire 24 in position. Thereafter, a balloon catheter 12 can be installedover the wire 24 and into the sinus ostium MO for dilation.

FIGS. 18A and 18B illustrate a device 210 and method for accessing anddilating a sinus ostium (e.g., maxillary sinus ostium MO) via a directsinus puncture technique, in contrast to a transnasal technique. Thisapproach can generally be done with the frontal sinus FS and themaxillary sinus MS. While a description of the device 210 and process isprovided for the maxillary sinus MS, it should be understood thatsimilar access devices 210 can be used with the frontal sinus FS.

In FIG. 18A, a trocar 212 is shown being advanced into the maxillarysinus MS via the canine fossa CF approach. The trocar 212 includes ahollow cannula 214 and a needle 216 contained within the lumen 218 ofthe cannula 214. The needle 216 has a sharp tip 220 for penetrating thethin bone surrounding the sinus. The needle 216 may be a solid piece orhaving one or more lumens therein. Once the cannula 214 is inside thesinus, the needle 216 is then removed and the cannula 214 serves as aguide catheter for subsequent devices. As an alternative to aneedle-cannula type of trocar 212, a hollow sharpened needle could beused as well.

Referring now to FIG. 18B, once the cannula 214 is in place, a wireguide 24 and an endoscope 222 can be introduced into the sinus. Thecannula 214 is pointed towards the ostium MO, which points the viewingfield 224 to the ostium MO. Manipulation of the wire guide 24 throughuse of a steering device 26 then delivers the wire guide 24 across theostium MO which may contain a blockage 200 as is shown in FIG. 18B.Optionally, an illumination member 226 can be placed in the nasal cavityto “back-light” the ostium MO and enhance the ability for the ostium MOto be seen, further aiding the ability to direct the wire guide 24across the ostium MO. Alternatively, a bright light placed at thenostril may be adequate to perform this back-lighting.

With the above-described “direct sinus puncture” technique such asthrough the canine fossa CF, various stabilization devices can beutilized to stabilize one or more of the various tools used foraccessing and/or treating the ostium. For example, as shown in FIG. 18C,a stabilization device 110 is shown stabilizing the cannula 214. Thestabilization device 110 could also be used to stabilize the wire guide24, the endoscope 222, trocar 212, and/or the balloon catheter 12.Similarly, any of the previously described stabilization devices can beutilized with the direct sinus puncture techniques.

FIGS. 19A, 19B, and 19C illustrate various arrangements and types ofendoscopes 222 a, 222 b, 222 c that can be used with this canine fossaCF approach. In FIG. 19A, the endoscope 222 a is a flexiblevisualization scope having a bundle of optical fibers 228. The endoscope222 a further includes a lumen 230 through which the wire guide 24 isfed. FIG. 19B shows a rigid endoscope 222 b used next to the wire guide24, inside cannula 214. FIG. 19C illustrates a similar arrangement tothat shown in FIG. 19B, but with an additional dual lumen catheter 232to better manage the positioning of the wire guide 24 relative to therigid endoscope 222 c. In all these approaches, the diameter of theendoscope 222 a, 222 b, 222 c used is preferably small, about 0.5 mm toabout 4 mm, and most preferably about 1 mm to about 2 mm. This allowsfor the use of a relatively small trocar and relatively small puncturesize. Preferred trocar diameters are from 0.7 mm to 4.2 mm (depending onthe size of the devices used with them), and more preferably from about1 mm to 2.5 mm, and most preferably 1.2 to 2.0 mm.

FIG. 20 illustrates the introduction of a balloon dilation catheter 12into the cannula 214 and into the sinus ostium MO, dilating the ostiumMO, and deforming and/or remodeling the uncinate process UP. To aid inthe positioning of the balloon 10, an optional endoscope 240 is placedin the nasal cavity may be used to visualize the catheter tip 12 crelative to the uncinate process UP.

Alternatively, the position of the balloon 10 may not require “realtime” visualization with an endoscope, if various markers on the wireguide and/or balloon catheter shaft as described earlier are utilized.For example, if the wire guide 24 includes markers, the marker that isseen at or near the ostium can be noted. Markers on the proximal portionof the wire guide 24 can then be used to determine the “depth” that thewire guide 24 has been advanced to reach the ostium. The ballooncatheter 12 can then be advanced a distance over the wire guide 24 apredetermined distance on the wire guide 24, such that the balloon 10 ispositioned at a desired position relative to the noted marker on thewire guide 24. Markers 62 on the shaft of the balloon catheter 12 canaid in this positioning. With this use of markers 62, the balloon 10 canbe confidently positioned in the desired region of the sinus ostium. Thedesired length of the balloon can be selected by viewing the computedtomography (CT) scans of the patient, which are part of a standarddiagnostic workup of the patient prior to any intervention.

Though not shown, once the maxillary ostium MO has been treated, theethmoids and/or frontal sinuses ES, FS can also be treated by this samecanine fossa access. The wire guide 24 can be manipulated into theethmoids and/or frontals, with subsequent dilation of the ostia of thesesinuses. Similar endoscopic visualization techniques as described abovecan also be utilized to assist in placement of the various devices suchas the wire guide 24 to these locations. In the case of the ethmoids, itmay be desirable to use a sharpened wire in lieu of a wire guide 24 topuncture into the wall of the ethmoid sinus air cells, followed byballoon dilation of the puncture.

As mentioned above, the frontal sinus FS can also be accessed directlyfrom outside the skull, through the wall of the frontal sinus FS tofacilitate treatment of the frontal sinus ostium FO. Rather than atrocar, the frontal sinus FS can be directly accessed through a minitrephination through the skin and the sinus wall, as is known in theart. With a mini-trephination, the access is performed with a drilltool. Once accessed, the frontal sinus ostium FO may be directlyaccessed with a wire guide 24. A preferred location for accessing thefrontal sinus FS is through the floor of the frontal sinus FS. Since thefrontal sinus FS is relatively small, and there is only one outflowtract and its position can be approximated relative to the nose,visualization may not be required to pass the wire guide 24 through thefrontal sinus ostium FO and into the nasal cavity. Standard endoscopicvisualization could be performed in the nasal cavity via the nostrils toobserve the wire guide 24 after it passes into the nasal cavity.Subsequent to passing the wire guide 24 into the frontal ostium FO, aballoon dilation catheter 12 can be positioned in the ostium FO todilate it.

Although the maxillary sinus MS is easily accessible via the caninefossa CF, it is important to control the depth of the initial punctureso as to not inadvertently advance the needle 216 too far andpotentially into the orbit O or elsewhere. FIG. 21 illustrates a trocar212 with a stop 250 secured to a portion of the trocar 212. The stop 250prevents the needle 216 from advancing too far into the sinus cavity. Inone aspect, the stop 250 is clamped on to either the needle 216 or thecannula 214 at a predetermined position. In a preferred embodiment ofthe invention, the stop 250 is adjustable and/or removable with respectto the fixation point (e.g., needle 216 or cannula 214). For example,the stop 250 may include one or more tightening members 252 such asscrews or the like that can be selectively tightened or loosen the stop250. Once the trocar 212 is inserted up to the stop 250, the stop 250 isremoved. The cannula 214 can then be advanced with little force, as thepuncture site has already been made.

FIG. 22 shows an alternative trocar 212 arrangement for improving thecontrol of the puncturing into the canine fossa CF. Here, the needle 216includes needle threads 216 a located on an exterior surface thereof.The threads 216 a of the needle 216 engage with a threaded hub 254 in athreaded interface. The threaded hub 254 may be in the form of a“clamshell” of two treaded pieces or halves 254 a, 254 b that surroundand engage the needle threads 216 a. The position of the threaded hub254 may be held fast by attachment to a stabilizing device such as thestabilizing devices 80, 110 shown in FIGS. 8 and 10. The needle 216 isthen advanced into the canine fossa CF by controlled rotation of theneedle 216. Once the needle 216 has penetrated or traveled the desiredamount, the threaded hub 254 is removed, and the cannula 214 is advancedto a desired position within the sinus. Alternatively, the threaded hub254 could be attached to a stabilizing device 80, 110 in a manner thatallows rotation of the threaded hub 254 about the needle threads 216 a,by utilizing a bearing surface (not shown) with the stabilizing device80, 110. The threaded hub 254 when rotated would controllably advancethe needle 216 into the sinus. In this manner, the needle 216 is notrotated.

Sometimes the desired direction and positioning for placing the trocar212 in the canine fossa CF does not provide good alignment with thelocation of the sinus ostium. In this case, a trocar 212 having aflexible tip 260 can be used, as shown in FIGS. 23A and 23B. In FIG.23A, the cannula 214 has a somewhat flexible curved tip 260, that, inFIG. 23A, is maintained straight by the presence of the needle 216. Thistrocar 212 is advanced into the sinus. Upon removal of the needle 216,the flexible tip 260 takes on its curved shape, more oriented to theostium MO. Thereafter a wire guide 24 is advanced across the ostium MO,preferably under the visual guidance of a flexible visualization scope262 as shown in FIG. 23B. The visualization scope 262 is preferablydimensioned such that it can be slidably passed through the cannula 214.The flexible visualization scope 262 includes a lumen or passageway 264for the wire guide 24. The flexible visualization scope 262 is able tobe oriented to place the visualization field 266 within the vicinity ofthe ostium MO. Manipulation of the curved tip 260 of the cannula 214 canassist in directing the wire guide 24 to and through the ostium MO. Alsoas shown, the nasal cavity can be back-lit using an illumination member268 to aid in seeing the ostium. Also, other tools and methods may beused as desired, such as, for example, the trocar 212 modificationsillustrated in FIGS. 21 and 22.

FIG. 24 illustrates another device and method for accessing themaxillary sinus ostium MO via the canine fossa CF. In this embodiment,two small punctures 270, 272 are made, side-by-side in the canine fossaCF region. A puncture device 210 like that disclosed in FIG. 18A may beused. For example, a rigid endoscope 274 is positioned in the cannula214 of the first puncture site 270. A wire guide 24 is then positionedin the cannula 214 of the second puncture site 272. One or more of thecannulas 212 may have a curved tip 260 to better access the maxillarysinus ostium MO. The wire guide 24 may then be positioned across theostium MO under the visualization of the rigid endoscope 274. A balloondilation catheter (not shown in FIG. 24) may then be advanced over thewire 24 to dilate the sinus. The ostial region may be back-lit using anillumination member 276.

FIGS. 25A and 25B illustrate a common anatomical characteristic presentin patients with sinusitis associated with the maxillaries, ethmoids,and frontals. The uncinate process UP is shown in close association withthe opposite wall, typically on the ethmoid bulla EB. This conditioncreates a narrow slit-like space called the infundibulum I. Themaxillary sinus ostium MO is actually located below (i.e., inferior to)the infundibulum I. FIG. 25B more clearly shows the “topography” of thestructures of the uncinate process UP and ethmoid bulla EB. It isbelieved that a narrowed infundibulum I may be part of the conditionleading to the patient's sinusitis, as well as one or more narrowedostia. In some patents, a narrowed infundibulum I may be the soleanatomical cause leading to sinusitis.

The previously described approaches to dilating the maxillary sinusostium MO may result in a widening of the infundibulum I by deforming orremodeling the uncinate process UP, as well as the widening of theostium MO itself. However, in some patients, the uncinate process UP maynot stay permanently deformed following removal of the dilation catheter12.

An alternative approach to widening the infundibulum I is illustrated inFIGS. 26A and 26B. One or more shim members 280 are placed in the gap ofthe infundibulum I to forcibly spread it away from the ethmoid bulla EBand improve drainage for the maxillary, frontal and portions of theethmoid sinus. In one preferred aspect of the invention, the one or moreshim members 280 are left in place after implantation. The shim members280 may remain in place for a temporary period of time or permanently.The sinus ostium may still be dilated with the use of a balloon dilationcatheter 12. FIG. 26B illustrates three such shim members 280 secured inthe infundibulum I. As seen in FIG. 26B, the gap is widened to exposethe maxillary sinus ostium MO.

FIGS. 27A and 27B illustrate one preferred embodiment of a shim member280. The shim members 280 may be dimensioned such that one or more sidesare longer than the remaining sides. For example, the shim member 280may be longer than it is wide, with a length dimension preferably about1 mm to about 6 mm in length, and more preferably about 2 mm to about 4mm in length. The shim members 280 may include one or more grippingmembers 282 on all or a portion of an exterior surface. The grippingmembers 282 may be formed as a serrated surface or even a plurality ofteeth or similar projections. As seen in FIGS. 27A and 27B, the grippingmembers 282 are located on opposing sides of the shim member 280 toallow for the shim member 280 to be rotated into position and held inplace.

The shim member 280 may include one or more engagement holes 284 thatare used for the delivery of the shim member 280. For example, theengagement holes 284 may be dimensioned to fit on the distal end of atool as shown in FIG. 28. The shim member 280 may be a permanentimplant, or more preferably a degradable bioabsorbable implant. Suitablematerials for a degradable shim member 280 include poly-lactic acid,poly-glycolic acid, poly-L-lactic acid or other materials such as thoseused in degradable sutures. It is believed that after the shim members280 are implanted in the infundibulum I, the uncinate process UP willremodel over time to maintain a widened infundibulum.

FIG. 28 illustrates a delivery tool 290 for use in the delivery of theshim member(s) 280. The delivery tool 290 includes an elongate torquedriver 292 constructed of a multi-layer, multi-filar drive shaft similarto that used in speedometer cables. The torque driver 292 is dimensionedto be positionable within a guide catheter 18 or the like. The shimmember 280 is connected to the torque driver 292 at its distal end 292a. The proximal end 292 b of the torque driver 292 is coupled to ahandle 294 or the like that is used to rotate the torque driver 292 (andattached shim member 280) in the direction of the arrows shown in FIG.28.

The guide catheter 18 is used to place the shim member 280 over theuncinate process UP and in the narrowed infundibulum I, initially in anarrow or “sideways” orientation. The torque driver 292 is then rotatedby rotation of the handle 294. Rotation of about 60 to about 90 degreeswill widen the infundibulum I as shown in FIG. 26B. The connectionbetween the torque driver 292 and the shim member 280 is disconnected.This could be done, for example, by reversing the rotational directionof the torque handle 294 and causing a weakened portion of theconnection to break. Alternatively, the torque driver 292 may befrictionally engaged with the holes 284 of the shim member 280.Retraction of the torque driver 292 in the proximal direction maydisengage the torque driver 292 from the shim member 280. Once place,the one or more shim members 280 will maintain the infundibulum I in awidened condition, while minimizing the interruption of the mucosa bythe presence of the shim member(s) 280.

Alternatively, as shown in FIG. 29, the infundibulum I can be widened bydelivery of an expandable stent 300, oriented more or less in theinfundibulum I. This stent 300 can be similar to that used in coronarystenting procedures, and can be either “self-expanding” or “balloonexpandable.” The geometry of the stent 300 may be tubular as is shown inFIG. 29.

The stent 300 can be placed in the infundibulum I using a ballooncatheter 12 and a wire guide 24. As one example, the stent 300 may bepositioned via a transnasal approach wherein the wire guide 24 isdirected along the infundibulum I up towards the frontal sinus ostium FO(as shown in FIG. 3C) and then deployed between the uncinate process UPand the ethmoid bulla EB.

While embodiments of the present invention have been shown anddescribed, various modifications may be made without departing from thescope of the present invention. The invention, therefore, should not belimited, except to the following claims, and their equivalents.

1. A method of treating a constricted passageway in a frontal sinus of apatient comprising: forming an artificial access passageway in a floorof the frontal sinus with a tool, the artificial access passagewayproviding an access point to the frontal sinus from directly outside theskull of the patient; inserting an elongate member through thepassageway, the elongate member having an inflation member disposedthereon; positioning the inflation member within the constricted sinuspassageway; and expanding the inflation member so as to expand at leasta portion of the constricted sinus passageway.
 2. The method of claim 1,wherein the inflation member is positioned within the constrictedpassageway under visualization.
 3. The method of claim 2, wherein thevisualization comprises placement of a visualization tool into the nasalcavity.
 4. The method of claim 3, wherein the visualization toolcomprises an endoscope.
 5. The method of claim 1, wherein the inflationmember comprises an expandable balloon.
 6. The method of claim 5,wherein the elongate member comprises a balloon catheter.
 7. The methodof claim 1, wherein the inflation member is positioned within theconstricted sinus passageway by advancing the elongate member over awire guide passing through the passageway.
 8. The method of claim 7,wherein the wire guide is positioned within the constricted passagewayunder visualization.
 9. The method of claim 8, wherein the visualizationcomprises placement of a visualization tool into the nasal cavity. 10.The method of claim 9, wherein the visualization tool comprises anendoscope.
 11. The method of claim 1, wherein the inflation member ispositioned using one or more markers contained thereon.
 12. The methodof claim 1, wherein the constricted sinus passageway comprises thefrontal sinus ostium.
 13. The method of claim 1, wherein the toolcomprises a drill tool.